Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary

NCT01397721 | Completed DMC

• 2 other identifiers: AAAD6395R01HL093081-01
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 4

Brief Summary

The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early COPD using imaging, gene expression profiling and peripheral cellular measures.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD); pulmonary vasculature; pulmonary hypertension; atherosclerosis; smokers; emphysema

Outcome Measures

Primary Outcomes (1)

• Change in cardiac structure and pulmonary vascular structure and function

  Cardiac structure: changes in right ventricular (RV) mass, RV mass/Right Ventricular End-Diastolic Volume (RV-EDV) Pulmonary structure: changes in total pulmonary vascular volume (TPVV) and pulmonary artery (PA) perfusion Function: changes in PA flow and distensibility

  Up to 2 years from start of study

Secondary Outcomes (3)

• Number of CD31+/CD42 endothelial microparticles (EMPs)

  Up to 2 years from the start of study

• Number of circulating endothelial cells (CEC)

  Up to 2 years from the start of study

• Number of endothelial progenitor cells (EPCs), involved in endothelial repair, are decreased

  Up to 2 years from the start of study

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately Study Subjects: MESA COPD will recruit approximately 360 participants from EMCAP at Columbia, and from MESA at Columbia; JH University; North Western University; and University of California. Cases will be defined according to the current American Thoracic Society/European Respiratory Society (ATS/ERS) definition of COPD of a post-bronchodilator capacity (FEV1/FVC) ratio \< 0.70 and classified as mild, moderate and severe as post-bronchodilator FEV1 of 80-100% predicted, 50-80% predicted and \< 50% predicted, respectively. Controls will be defined in the above sampling frame as those with normal lung function (pre-bronchodilator FEV1/FVC ratio \>= 0.70, and no restrictive ventilatory defect.

You may qualify if:

• age 50-79 years at time of enrollment
• ever smokers (10 or more pack-years)
• participation in MESA or EMCAP studies

You may not qualify if:

• clinical cardiovascular disease (left congestive heart failure (CHF), valve disease, coronary artery disease (CAD), stroke, or congenital heart disease),
• asthma, pulmonary embolism or lung disease other than COPD,
• weight \> 300 lbs,
• chronic renal insufficiency (\[estimated glomerular filtration rate (eGFR)\] \< 45 mL/min/1.73 m2),
• atrial fibrillation, and
• contraindications to magnetic resonance imagine (MRI), gadolinium, albuterol or spirometry testing.

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

UCLA Research Center

Alhambra, California, 91801, United States

Location

Northwestern University Medical School

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be stored at Columbia and at University of Vermont, identified only by study ID and following standard procedures. It will be accessible only to study investigators and, if the participant approves, outside investigators following MESA/NIH protocols and with IRB approval. Blood will be kept indefinitely.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Atherosclerosis; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• R. Graham Barr, MD, DrPh

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Irving Associate Professor of Medicine and Associate Professor of Epidemiology

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 20, 2011
• Study Start: May 1, 2009
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (4)